Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K010447
    Device Name
    MODIFICATION TO ACTICOAT FOAM DRESSING
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    2001-03-15

    (30 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002466
    Device Name
    ACTICOAT COMPOSITE DRESSING
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    2001-02-16

    (189 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K001519
    Device Name
    ACTICOAT 7 DRESSING
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    2000-10-06

    (143 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992221
    Device Name
    ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    2000-06-07

    (342 days)

    Product Code
    FRO, MGP
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.
    Device Description
    Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-density polyethylene (HDPE) mesh. The sustained release of silver actively protects the wound site from bacterial and fungal contamination. The dressing will be sold in a variety of sizes.
    Ask a Question
    K Number
    K000051
    Device Name
    ACTICOAT FOAM DRESSING
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    2000-04-05

    (89 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K983833
    Device Name
    ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
    Manufacturer
    WESTAIM BIOMEDICAL, INC.
    Date Cleared
    1998-12-10

    (41 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    WESTAIM BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Acticoat® Composite Wound Dressing is an effective barrier to bacterial penetration. The barrier function of the dressing may help reduce infection in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, donor sites, and surgical wounds. Acticoat® dressings may be used over debrided and grafted partial thickness wounds.
    Device Description
    Acticoat® Composite Wound Dressing is a 3-ply dressing consisting of an absorbent rayon core with an upper layer of polyurethane film and a lower layer of silvercoated high density polyethylene mesh designed to be a barrier against microbial infections of a wound. The silver in the coating is an alloy of silver and oxygen. The coating is highly porous, and the film has enhanced solubility in water-based fluids. Additionally, the performance characteristics of the Acticoat® Composite Wound Dressing are similar to those found in untreated gauze-based dressings in the areas of absorptivity and moisture content. abrasion resistance, adhesion, and tensile strength.
    Ask a Question

    Page 1 of 1